MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 ECHELON; CATHETER, CONTINUOUS FLUSH

Model Number	145-5091-150
Medical Device Problem Codes	Device Damaged by Another Device (2915); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that during intraoperative coil delivery, the spring coil felt stuck.The echelon 10 microcatheter and spring coil were removed and examined outside the body, revealing that the spring coil protruded laterally from the marker point at the distal tip of the microcatheter.There was no friction or difficulty during insertion of the guidewire/stylet.The microcatheter was replaced with a medtronic product to complete the procedure.No patient symptoms or complications were associated with this event.The patient was undergoing embolization surgery for treatment of an aneurysm.It was noted the patient's vessel tortuosity was normal.Vascular access was obtained via the femoral artery.The reported device and any accessory devices were prepared, and the catheter was flushed, as indicated in the instructions for use (ifu).Aside from the puncture, there was no damage to the catheter and no kink or damage on the coil guidewire/pushwire/stylet.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Additional information was received stating that the lesion was a posterior communicating artery aneurysm.The coil used was a medtronic coil, but the specific model is unknown.The cause of the catheter puncture was not determined.
Additional Manufacturer Narrative
Product analysis as found condition (condition of returned device): an echelon-10 micro catheter was returned for analysis within a shipping box and within a sealed biohazard pouch.The unknown coil used during the event was not returned.Visual inspection/damage location details: upon visual examination, no issues were found with the echelon-10 hub or catheter body.The distal tip was noted to be pre-shaped and additionally shaped.The distal tip was found to be damaged.Upon further inspection there appeared to be a puncture at proximal end of distal marker band.No other anomalies were observed.Testing/analysis (including sem reports): the echelon-10 total length was measured to be ~155.6cm.The echelon-10 useable length was measured to be ~148.2cm which is within specification.The echelon-10 micro catheter was flushed, water exited from puncture and distal tip.One in house guidewire was able to pass through the echelon-10 micro catheter hub and subsequently through the inner lumen; however, exited puncture at distal tip.Conclusion: based on the device analysis and reported information, the customer¿s report of ¿catheter puncture¿ was confirmed.The echelon-10 distal tip was found to be punctured.It is possible additional shaping of the echelon-10 distal tip contributed to the event; however, the root cause could not be determined.Based on the device analysis and reported information, the customer¿s report of ¿catheter resistance during device delivery¿ was confirmed.It is possible the puncture at distal tip contributed to the event; however, the root cause could not be determined.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Additional information received.The coil became stuck in the distal section of the catheter.It was removed from the introducer sheath, and it is unknown whether there was any kink or damage to the coil after removal.

• Brand Name: ECHELON
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: justin ellis ; 9775 toledo way; irvine, CA 92618 ; 7635265677
• MDR Report Key: 23802911
• Report Number: 2029214-2025-02620
• Device Sequence Number: 13094809
• Product Code: KRA
• UDI-Device Identifier: 00847536006256
• UDI-Public: (01)00847536006256(17)270317(10)D025846
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K093750
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/05/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 145-5091-150
• Device Catalogue Number: 145-5091-150
• Device Lot Number: D025846
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2025
• Supplement Date Received by Manufacturer: 12/16/2025; 02/04/2026
• Initial Report FDA Received Date: 12/15/2025
• Supplement Report FDA Received Date: 01/14/2026; 02/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/17/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Sex: Female